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72 SGTC India Jobs
Quality Engineer - Supplier Controls
SGTC India
posted 4d ago
Job Role Insights
Key skills for the job
Job Description
What you will do:
- Responsible for the development, revision, maintenance, and inactivation of the local Stryker site procedures ensuring the alignment with the corporate guidelines for purchasing controls.
- Collaborate with Procurement, Site Quality, Regulatory, and Regional Supplier Quality teams on strategic initiatives and sustaining activities to support successful supplier quality controls programs.
- Support tracking and reporting of KPI and other metrics associated with supplier performance. Articulate detailed supplier performance results and trends to appropriate levels of management.
- Support Third Party inspection (FDA, Notified Body etc. ) and Stryker Corporate audits of the quality system.
- Execute supplier quality agreements (SQA) and Supplier Change Control Agreements (CCA)
- Provide best in class support to our business partners across Stryker for successful implementation of compliant and efficient Supplier Quality Controls programs.
- Support local initiatives and projects for improvement, and implementation of processes to build a best in-class Supplier Quality Controls organization.
- Work with site and divisional counterparts to own Corporate Purchasing Controls NC s and CAPA s (containment actions, root cause, corrective/preventive action, etc. ).
- Additional duties, as assigned.
What you need:
Required:
- B. Tech (Electronics / Electrical / Mechanical) with 2-5 years of experience in Supplier quality.
- Knowledge of ISO 13485, FDA, EUMDR and regional medical device regulatory requirements.
- Ability to effectively communicate information to team members, leaders, management, and suppliers.
- Experience supporting third-party inspection (FDA, Notified Body etc. ) within the medical device industry.
- Proficient in MS Office Suite (including Word, Excel, Power Point etc).
- Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs).
Preferred:
- Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard / regulation) and EUs Medical Device Directive.
- Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams
- Preferred German Language exposure .
- ISO 13485 Lead Auditor certification or equivalent
Employment Type: Full Time, Permanent
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